EVOS 71174989Recalls & reported problems
Smith & Nephew, Inc. · T8 HOLDING SLEEVE · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556500743), received between Mar 14, 2021 and Dec 16, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Loose or Intermittent Connection3
- Detachment of Device or Device Component1
- Mechanical Problem1
- Naturally Worn1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
T WAS REPORTED THAT DURING TRAUMA SURGERY, THE SCREW CAPTURE SPRING OF ONE (1) T8 HOLDING SLEEVE WAS NO FOUND TO BE WORKING PROPERLY. THE SPRING INSIDE WAS MISSING THAT KEEPS TENSION FOR ITEM TO GRASP SCREWS PROPERLY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20939355 ↗MalfunctionNov 9, 2021Break; Unintended Movement; Break; Unintended Movement
IT WAS REPORTED THAT, A BEAD FROM THE CAPTURING MECHANISM OF A T8 HOLDING SLEEVE HAS COME LOOSE AND BROKE, THEREFORE, IT NO LONGER WORKS. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12780318 ↗MalfunctionAug 30, 2021Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THREE (3) DEVICES, TWO (2) T7 LINEAR DRIVER SHAFT W/ AO QC AND A T8 HOLDING SLEEVE, ARE WORN AND BROKEN AND NEED TO BE REPLACED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12388970 ↗MalfunctionJun 2, 2021Loose or Intermittent Connection; Mechanical Problem; Loose or Intermittent Connection; Mechanical Problem
IT WAS REPORTED THAT, UPON INSPECTION, A T8 HOLDING SLEEVE WAS FOUND TO BE UNABLE TO HOLD AND CAPTURE ANY DRIVER. NO CASE INVOLVED; THEREFORE, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11918370 ↗MalfunctionApr 18, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT, THE T8 HOLDING SLEEVE DOES NOT CAPTURE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11683481 ↗MalfunctionApr 4, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THET8 HOLDING SLEEVE DOES NOT CAPTURE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11611988 ↗MalfunctionMar 14, 2021Break; Break
IT WAS REPORTED THAT, A HOLDING SLEEVE IS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11478888 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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